Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

NCT02284269 | Unknown

• 1 other identifier: PMDA-A2602
• Study Type: observational
• Target: 18,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions. In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  up to 3 years

Secondary Outcomes (8)

• Incidence of cardiovascular events

  up to 3 years

• Incidence of cancer

  up to 3 years

• The change from baseline in vital signs and laboratory data

  Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration

• Incidence of other adverse events

  up to 3 years

• Incidence of drug-related adverse events

  up to 3 years

Interventions

SGLT2 Inhibitors DRUG

Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pharmaceuticals and Medical Devices Agency, Japan: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: observational
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2020
• Last Updated: April 4, 2016

Record last verified: 2016-03